A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Dupilumab for the Treatment of Pruritus of Lichen Simplex Chronicus (LSC) in Adults

Sanofi64 sites in 13 countries138 target enrollmentNovember 25, 2024

ConditionsLichen Simplex Chronicus

InterventionsDupilumab Placebo

DrugsDupilumab Placebo

Overview

Phase: Phase 3
Intervention: Dupilumab
Conditions: Lichen Simplex Chronicus
Sponsor: Sanofi
Enrollment: 138
Locations: 64
Primary Endpoint: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
Status: Active, not recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC.

Study details include:

The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.

Registry

clinicaltrials.gov

Start Date

November 25, 2024

End Date

August 31, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the following criteria apply (at screening and baseline unless otherwise specified):
•Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
•Participants with moderate-to-severe LSC, as defined by Investigator's Global Assessment (IGA) score ≥3 and one or more of the following:
•at least 1 single anogenital lesion;
•at least 2 lesions including 1 lesion of ≥3 cm in diameter;
•at least 1 severe lesion (IGA score = 4).
•History of LSC for at least 6 months prior to the screening visit.
•On the Worst-Itch Numerical Rating Scale (WI-NRS) ranging from 0 to 10, participants must have an average worst-itch of LSC score of ≥7 in the 7 days prior to Day
•A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score. For participants who do not have at least 4 daily scores reported during the 7 days immediately preceding the planned randomization date, randomization can be postponed until this requirement is met, but without exceeding the 28-day maximum duration of the screening period.
•History of failing a 2-week course of medium-to-superpotent topical corticosteroid (TCS) +/- topical calcineurin inhibitor (TCI) for the treatment of LSC within the last 6 months, unless TCS/TCI are medically not advisable. Patients with documented systemic treatment for LSC (other than antihistamines) in the past 6 months are also considered as inadequate responders to topical treatments and are potentially eligible for treatment with dupilumab after appropriate washout.

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply (at screening and baseline unless otherwise specified):
•Participants diagnosed with active lesions of prurigo nodularis (broadly distributed nodules) or active lesions of atopic dermatitis (AD) within 6 months, contact dermatitis, psoriasis, cutaneous T-cell lymphoma (CTCL) XE "CTCL" \\f Abbreviation \\t "cutaneous T-cell lymphoma" (or suspected of CTCL), vulvar lichen planus, or vulvar lichen sclerosus.
•Presence of skin morbidities other than LSC that, in the opinion of the Investigator, may interfere with the assessment of the study outcomes. For example: scabies, insect bite, folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, lichen planus hypertrophicus.
•Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
•Severe psychiatric disease that, in the Investigator's judgement, would affect the study intervention evaluation.
•Having received or planning to use any of the treatments within the timeframe as specified in the protocol.
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Arms & Interventions

Dupilumab

Dupilumab subcutaneous injection as per protocol

Intervention: Dupilumab

Placebo

Placebo subcutaneous injection as per protocol

Intervention: Placebo

Outcomes

Primary Outcomes

Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24

Time Frame: Week 24

Worst-Itch numerical rating score (WI-NRS) is a patient report outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

Secondary Outcomes

Absolute change in weekly average of daily WI-NRS from baseline to Week 24(Baseline to Week 24)
Percentage change in weekly average of daily WI-NRS from baseline to Week 24(Baseline to Week 24)
Proportion of participants with IGA 0 or 1 score for LSC at Week 12 and Week 24(Week 12 and 24)
Absolute change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24(Baseline to Week 24)
Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24(Baseline to Week 24)
Absolute change in ItchyQoL score from baseline to Week 24(Baseline to Week 24)
Absolute change in DLQI total score from baseline to Week 24(Baseline to Week 24)
Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab(Baseline through Week 36)
Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12(Week 12)
Proportion of participants with both an improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 and an IGA 0 or 1 score for LSC at Week 24(Baseline through Week 24)
Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)(Baseline through Week 36)